Title:  QC Analyst I

Job Summary

Performs various quality control tests on raw materials, in-process and final product using established Standard Operating Procedures (SOPs) and working in accord with current Good Manufacturing Practices (cGMPs)

Area Of Responsibility

• Perform analytical quality control tests and assays for release, stability, and complaint follow-up on raw materials, in-processing and final products following GLPs
• Perform USP test methods and EP test methods
• Perform the quality control tests and assays, and monitor equipment (i.e. water systems, environmental chambers).  Maintain records of the data in manual logs following GDPs.
• Wash glassware, prepare reagents, solutions, and equipment for chemical tests and assays
• Send samples to contract laboratories and collect test data

• Use basic lab instruments
• Perform monthly equipment/instrument maintenance and cleaning
• Follow work-flow procedures from receiving test samples, monitoring inventories, to waste disposal
• Train towards Visual Inspection qualifications
• Other duties as assigned

Work Conditions:

• Office
• Lab environment with moderate noise, heat, open flame and radiation in specific areas requiring appropriate safety equipment (i.e. gloves, lab coat, safety glasses and respirator)
• Work with non-hazardous and hazardous chemicals, toxic metals and radioactive materials
• Exposure to or use of syringes and needles
• Requires access/work in chemical fume hoods
• Requires access/work in class 100K, 10K or 100 clean room (mask and boots in conformance with environmental dress codes)

Physical Requirements:

• Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, hear and talk
• Close vision
• Lift up to 25 lbs.
• Operate computer/office machines
• Ability to wear Personal Protection Equipment

Travel Estimate

Up to 5%

Education and Job Qualification

• BS in chemistry or related scientific major required
• Good oral and written communication skills
• Ability to follow specific instruction and report assay results (i.e. written SOPs)
• Proficient with wet chemical methods and tests (USP, ACS, Titration, Limit tests, etc.)
• Fundamental knowledge of chemical principles
• Proficient with basic laboratory instrumentation
• Basic computer skills
• Works under general supervision following established procedures

Experience

• Minimum 0-2 years related experience preferred
• Use of Trackwise software